Medtronic Gets FDA Warning Letter Concerning CRM Division

Medtronic says the FDA has sent the firm a warning letter ordering changes In its cardiac rhythm management operations. The letter cited problems with supplier qualification and control issues, the company’s reporting timeliness and review and documentation of field action recommendations. Medtronic’s CRM business is the company’s largest division. (Click here for more)

“Medtronic Gets FDA Warning Letter After Inspection” – Reuters (11/18/09)

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